6/09/2020
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Although electronic consent is permitted and encouraged by the Food and Drug Administration (FDA), many stakeholders have continued to use paper consents. Investigators have been having difficulties obtaining informed consent from subjects during the COVID-19 restrictions, especially from patients in isolation. The FDA developed the MyStudies application in 2018 as a tool to collect real-world data from subjects. Currently, it is available as the COVID MyStudies app in mobile device app stores for download. The app is intended to provide a reliable and regulatory-compliant way to obtain electronic informed consent. Methods of obtaining informed consent are covered in the FDA guidance on clinical trials during COVID-19. Once the subject or their legally authorized representative signs the electronic consent, they receive an electronic copy. The investigator can either print or securely transfer the electronically signed consent to their records. For more information on the technical background of the app, visit the FDA’s website here.
You may be interested in our related recorded webinars:
1. ‘Remote Monitoring Operations and Maintaining HIPAA, GCP, and COVID-19 Restrictions’ including a helpful Q&A reference free with purchase.
The focus is on the sponsor/CRO’s perspective. Purchase by clicking here.
2. ‘A Case for Sponsor Monitoring Remote Access to a Site’s EMR!’
The focus is on the site’s perspective. Purchase by clicking here.
Recorded webinars will be available for 10 days after purchase.
- The Clinical Pathways Team
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